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RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00968253
Recruitment Status : Completed
First Posted : August 28, 2009
Results First Posted : May 31, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Acute Lymphocytic Leukemia
Interventions Drug: Everolimus (RAD001)
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Doxorubicin
Drug: Dexamethasone
Drug: Mesna
Drug: Methotrexate
Drug: Ara-C (Cytarabine)
Drug: Methylprednisone
Drug: G-CSF
Enrollment 24
Recruitment Details Recruitment Period: November 18, 2009 to March 21, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Phase I: RAD001 5 mg + Combination Chemo Phase I: RAD001 10 mg + Combination Chemo Phase II: MTD RAD001 + Combination Chemo
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Everolimus (RAD001) beginning oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.

Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher.

RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.

Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher.

RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.

Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher.

Period Title: Overall Study
Started 3 9 12
Completed 3 6 5
Not Completed 0 3 7
Reason Not Completed
Death             0             0             2
Withdrawal by Subject             0             0             1
Disease Progression             0             3             3
Adverse Event             0             0             1
Arm/Group Title Phase I: RAD001 5 mg + Combination Chemo Phase I: RAD001 10 mg + Combination Chemo Phase II: MTD RAD001 + Combination Chemo Total
Hide Arm/Group Description RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. Total of all reporting groups
Overall Number of Baseline Participants 3 9 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 9 participants 12 participants 24 participants
29
(24 to 52)
24
(11 to 59)
30
(14 to 64)
25
(11 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 9 participants 12 participants 24 participants
Female
1
  33.3%
3
  33.3%
3
  25.0%
7
  29.2%
Male
2
  66.7%
6
  66.7%
9
  75.0%
17
  70.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 9 participants 12 participants 24 participants
3 9 12 24
1.Primary Outcome
Title Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)
Hide Description

The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study.

A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs.

Time Frame Following first two dose cycles (21 days/each), up to 42 days
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Hide Analysis Population Description
Maximum tolerated dose was an outcome measure for the phase I portion of this study only. MTD was already established, therefore, not analyzed on the participants for the phase II portion of this study.
Arm/Group Title Phase I: RAD001 5 mg + Combination Chemo Phase I: RAD001 10 mg + Combination Chemo Phase II: MTD RAD001 + Combination Chemo
Hide Arm/Group Description:
RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.

RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.

Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher.

Overall Number of Participants Analyzed 3 6 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  16.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase I: RAD001 5 mg + Combination Chemo, Phase I: RAD001 10 mg + Combination Chemo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Maximum tolerated dose
Estimated Value 5
Estimation Comments Maximum tolerated dose (MTD) of Everolimus measured in mg/day in combination with HyperCVAD
2.Primary Outcome
Title Overall Response Rate (OR) Where OR = CR + CRp + CRi
Hide Description Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl.
Time Frame 8 courses of treatment, up to 24 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I: RAD001 5 mg + Combination Chemo Phase I: RAD001 10 mg + Combination Chemo Phase II: MTD RAD001 + Combination Chemo
Hide Arm/Group Description:
RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
Overall Number of Participants Analyzed 3 9 12
Measure Type: Number
Unit of Measure: percentage of participants
33 33 33
3.Secondary Outcome
Title Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)
Hide Description Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures.
Time Frame Up to 20 cycles of study drugs (21 day cycles) or till disease progression
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I: RAD001 5 mg + Combination Chemo Phase I: RAD001 10 mg + Combination Chemo Phase II: MTD RAD001 + Combination Chemo
Hide Arm/Group Description:
RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
Overall Number of Participants Analyzed 3 9 12
Measure Type: Number
Unit of Measure: participants
Complete Remission 1 2 3
Complete Remission without platelet recovery 0 0 1
CR with incomplete blood count recovery 0 1 0
Partial Remission 1 1 0
Nonresponder 1 5 8
Time Frame Adverse event collection for 8 courses of trial (21 day course), up to 24 weeks; SAEs reported from time consent is signed, during the course of treatment and within 30 days after the last day of active treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I: RAD001 5 mg + Combination Chemo Phase I: RAD001 10 mg + Combination Chemo Phase II: MTD RAD001 + Combination Chemo
Hide Arm/Group Description RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles. RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
All-Cause Mortality
Phase I: RAD001 5 mg + Combination Chemo Phase I: RAD001 10 mg + Combination Chemo Phase II: MTD RAD001 + Combination Chemo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: RAD001 5 mg + Combination Chemo Phase I: RAD001 10 mg + Combination Chemo Phase II: MTD RAD001 + Combination Chemo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      7/9 (77.78%)      11/12 (91.67%)    
Blood and lymphatic system disorders       
Febrile Neutropenia  1  0/3 (0.00%)  0 5/9 (55.56%)  5 1/12 (8.33%)  1
Neutropenic Fever  1  1/3 (33.33%)  1 0/9 (0.00%)  0 5/12 (41.67%)  10
Pancytopenia  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Hyponatremia  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Cardiac disorders       
Chest Pain  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Sinus Tachycardia  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Gastrointestinal disorders       
Mucositis/Stomatitis  1  0/3 (0.00%)  0 4/9 (44.44%)  5 1/12 (8.33%)  1
General disorders       
Multi-Organ Failure  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Death  1  0/3 (0.00%)  0 2/9 (22.22%)  2 3/12 (25.00%)  3
Infections and infestations       
Septic Shock  1  0/3 (0.00%)  0 0/9 (0.00%)  0 2/12 (16.67%)  2
Infection - E Coli Bacterium  1  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  1
Pneumonia  1  0/3 (0.00%)  0 3/9 (33.33%)  3 2/12 (16.67%)  2
Metabolism and nutrition disorders       
Alanine aminotransferase increased  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Aspartate aminotransferase increased  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Renal and urinary disorders       
Cystitis  1 [1]  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pleural effusions  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Abdominal pain, Bladder Spasms
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I: RAD001 5 mg + Combination Chemo Phase I: RAD001 10 mg + Combination Chemo Phase II: MTD RAD001 + Combination Chemo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      9/9 (100.00%)      12/12 (100.00%)    
Blood and lymphatic system disorders       
Blood/Bone Marrow (Other)  1 [1]  0/3 (0.00%)  0 0/9 (0.00%)  0 2/12 (16.67%)  2
Febrile neutropenia  1  0/3 (0.00%)  0 4/9 (44.44%)  5 7/12 (58.33%)  9
Hemoglobin decreased  1  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  2
Hemorrhage/Bleeding (Other  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Cardiac disorders       
Cardiac General (Other)  1 [2]  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  1
Chest pain  1  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  1
Hypotension  1  0/3 (0.00%)  0 4/9 (44.44%)  4 2/12 (16.67%)  2
Sinus tachycardia  1  0/3 (0.00%)  0 1/9 (11.11%)  2 2/12 (16.67%)  2
Eye disorders       
Vision blurred  1  0/3 (0.00%)  0 1/9 (11.11%)  2 1/12 (8.33%)  1
Gastrointestinal disorders       
Abdominal pain  1  0/3 (0.00%)  0 5/9 (55.56%)  7 1/12 (8.33%)  1
Constipation  1  0/3 (0.00%)  0 4/9 (44.44%)  4 1/12 (8.33%)  1
Dehydration  1  0/3 (0.00%)  0 2/9 (22.22%)  3 1/12 (8.33%)  1
Dental prosthesis, soreness  1  1/3 (33.33%)  1 0/9 (0.00%)  0 0/12 (0.00%)  0
Diarrhea  1  0/3 (0.00%)  0 5/9 (55.56%)  7 5/12 (41.67%)  5
Dry mouth  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Dysphagia  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Gastrointestinal pain  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Hemorrhoidal hemorrhage  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Infectious colitis  1  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  3
Mucositis oral  1  0/3 (0.00%)  0 6/9 (66.67%)  8 5/12 (41.67%)  8
Nausea  1  0/3 (0.00%)  0 3/9 (33.33%)  3 3/12 (25.00%)  3
Vomiting  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  2
General disorders       
Constitutional Symptoms (Other)  1 [3]  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Fatigue  1  0/3 (0.00%)  0 1/9 (11.11%)  2 6/12 (50.00%)  6
Fever  1  2/3 (66.67%)  2 4/9 (44.44%)  6 1/12 (8.33%)  1
Multi-organ failure  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Pain (Other)  1 [4]  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Infections and infestations       
Abdominal infection  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Infection (Other)  1 [5]  0/3 (0.00%)  0 4/9 (44.44%)  4 6/12 (50.00%)  10
Infection (Other)  1 [6]  0/3 (0.00%)  0 5/9 (55.56%)  11 6/12 (50.00%)  9
Pneumonia  1  0/3 (0.00%)  0 4/9 (44.44%)  4 4/12 (33.33%)  5
Sepsis  1  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  1
Tooth infection  1  0/0  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Upper respiratory infection  1  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  1
Urinary tract infection  1  1/3 (33.33%)  1 1/9 (11.11%)  2 2/12 (16.67%)  2
Investigations       
Alanine aminotransferase increased  1  2/3 (66.67%)  2 3/9 (33.33%)  10 8/12 (66.67%)  10
Aspartate aminotransferase increased  1  1/3 (33.33%)  1 3/9 (33.33%)  7 8/12 (66.67%)  9
Bilirubin increased  1  0/3 (0.00%)  0 1/9 (11.11%)  1 6/12 (50.00%)  8
Blood glucose increased  1  0/3 (0.00%)  0 0/9 (0.00%)  0 4/12 (33.33%)  8
Creatinine increased  1  0/3 (0.00%)  0 2/9 (22.22%)  3 3/12 (25.00%)  3
Neutrophil count decreased  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Platelet count decreased  1  1/3 (33.33%)  1 0/9 (0.00%)  0 1/12 (8.33%)  2
Metabolism and nutrition disorders       
Hypercalcaemia  1  0/3 (0.00%)  0 3/9 (33.33%)  3 1/12 (8.33%)  1
Metabolic/Laboratory (Other)  1 [7]  3/3 (100.00%)  3 1/9 (11.11%)  2 1/12 (8.33%)  1
Serum albumin decreased  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Serum magnesium increased  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Serum potassium increased  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Serum sodium decreased  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Serum potassium decreased  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
HYPERKALEMIA  1  0/3 (0.00%)  0 0/9 (0.00%)  0 3/12 (25.00%)  3
HYPOKALEMIA  1  1/3 (33.33%)  1 1/9 (11.11%)  1 4/12 (33.33%)  5
HYPOMAGNESEMIA  1  1/3 (33.33%)  1 1/9 (11.11%)  1 1/12 (8.33%)  1
HYPERMAGNESEMIA  1  0/3 (0.00%)  0 2/9 (22.22%)  2 0/12 (0.00%)  0
Hypoalbuminemia  1  1/3 (33.33%)  1 2/9 (22.22%)  2 1/12 (8.33%)  1
Hyperuricemia  1  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  1
Hyperphosphatemia  1  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  1
Hyperglycemia  1  0/3 (0.00%)  0 0/9 (0.00%)  0 3/12 (25.00%)  6
Hypernatremia  1  0/0  0 0/9 (0.00%)  0 2/12 (16.67%)  3
Hypocalcemia  1  0/0  0 0/9 (0.00%)  0 4/12 (33.33%)  4
Musculoskeletal and connective tissue disorders       
Back pain  1  0/3 (0.00%)  0 2/9 (22.22%)  2 2/12 (16.67%)  2
Muscle weakness  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Musculoskeletal (Other)  1 [8]  0/3 (0.00%)  0 3/9 (33.33%)  3 0/12 (0.00%)  0
Pain in extremity  1  0/3 (0.00%)  0 2/9 (22.22%)  2 4/12 (33.33%)  4
Nervous system disorders       
Headache  1  0/3 (0.00%)  0 4/9 (44.44%)  5 3/12 (25.00%)  4
Peripheral motor neuropathy  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Peripheral sensory neuropathy  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Psychiatric disorders       
Confusion  1  1/3 (33.33%)  1 0/9 (0.00%)  0 1/12 (8.33%)  1
Depression  1  0/3 (0.00%)  0 2/9 (22.22%)  2 0/12 (0.00%)  0
Renal and urinary disorders       
Bladder hemorrhage  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Bladder spasm  1  0/3 (0.00%)  0 1/9 (11.11%)  2 0/12 (0.00%)  0
Cystitis  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Hemoglobin urine positive  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/3 (33.33%)  1 0/9 (0.00%)  0 1/12 (8.33%)  1
Dyspnea  1  0/3 (0.00%)  0 1/9 (11.11%)  1 3/12 (25.00%)  3
Hiccough  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Sinusitis  1  0/0  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  0/3 (0.00%)  0 0/9 (0.00%)  0 1/12 (8.33%)  1
Edema limbs  1  0/3 (0.00%)  0 1/9 (11.11%)  1 1/12 (8.33%)  1
Rash acneiform  1  0/3 (0.00%)  0 1/9 (11.11%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Epistaxis
[2]
cardiomyopathy, tachycardia
[3]
sore mouth
[4]
Left Flank
[5]
Bacteria, Acremonium fungemia
[6]
ESCHERICHIA COLI, STENOTROPHOMONAS, HERPES
[7]
Elevated amylase and lipase
[8]
Bilateral Edema
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marina Konopleva, MD, PHD/Professor, Leukemia
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00968253     History of Changes
Other Study ID Numbers: 2009-0100
NCI-2011-01814 ( Registry Identifier: NCI CTRP )
First Submitted: August 27, 2009
First Posted: August 28, 2009
Results First Submitted: December 22, 2016
Results First Posted: May 31, 2018
Last Update Posted: February 27, 2019